Safdari Reza¹, Choobineh Hamid ², Rampisheh Zahra³ and Vahedi barzoki Akram ^4*

¹Professor of Health Information Management Department, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran. ²School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran.; Member of Specialized team of Royan Research Institute, Tehran University of Medical Sciences, Tehran, Iran. ³Community Medicine Specialist, Hospital Management and Clinical Excellence Office, Curative Affaires Deputy, MOH, Tehran, Iran. ⁴Health Information Technology, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran. Corresponding Authors Email : vahedi_8466@yahoo.com

DOI : https://dx.doi.org/10.13005/bpj/943

Abstract

According to increasing of infertility in Iran and importance of identifying factors affecting infertility and its costs, the aim of this study was analysis of data elements of infertility registration system in Iran and comparison with other leading countries in this regard. This is a descriptive-comparative study and was done in 2015. Research resources were Infertility registration system in America, Britain, Australia, Belgium and Japan, which were retrieved from the Internet and also documents, forms and systems in Iran. These data were entered in data extracting form.Then, data elements of the Iran and selected countries were compared and the results were presented in descriptive tables. The results of this study were divided in three categories and each category has some sub-categories. First category was included demographic information of patients and physician, in second category, there was some information such as menstrual status, sexual, reproductive history, medical history, surgery and medication. Also, the third category was included causes of infertility, male and female infertility tests and treatments. According to the increasing prevalence of infertility in Iran and the absence of a comprehensive infertility registration system, need to develop a comprehensive registration system is clear. Also, update and add new variables to improve the system are recommended after launch.

Keywords

electronic registration; infertility; registration system

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Copy the following to cite this article: Reza S, Hamid C, Zahra R, Akram V. B. Analysis of Infertility Electronic Registration System Data Elements, A Comparative Study. Biomed Pharmacol J 2016;9(1)

Copy the following to cite this URL: Reza S, Hamid C, Zahra R, Akram V. B. Analysis of Infertility Electronic Registration System Data Elements, A Comparative Study. Biomed Pharmacol J 2016;9(1). Available from: http://biomedpharmajournal.org/?p=6850

Introduction

In today’s society most of the information required by the country’s health system, is related to health information. So all health activities would be documented and recorded manually or computerized. Registry system, is a set of patients, related data with a particular diagnosis or a specific action. Activities such as tracking patterns of referral chain of patients ,evaluation and follow-up processes of quality of  patients care, providing  essential data for valuable sources of health care systems executive planning and  hospital program marketing will be possible  by  efficient registry system^(1,2). It is evident that a large amount of documentation related to patient’s diagnostic and therapeutic care is stored in health care centers. The total medical records that information, such as numerical results of the laboratory tests , the symptoms and images of each patient is saved on it, make up the core hospital information system⁽³⁾. Health care systems requires accurate estimation of the size of public health problems in order to plan to meet future needs accurately and precisely.

Infertility is one of the common problems of human society⁽⁴⁾.Infertility definition according to the World Health Organization is known as “reproductive system diseases with the failure to achieve pregnancy after 12 months or more of unprotected sexual intercourse”⁽⁵⁾. Infertility, in today’s world has become as one of the medical problems and a social concern. This event is an exciting and frustrating circumstances for couples and is associated with social, emotional, physical and financial consequences^(4,6).The other factors that affects many under treatment couples, are the  imposed  medical care costs, lack of adequate insurance coverage. Infertility etiology is different and its trend may be affected by various environmental, and genetic factors.  Even with the current therapies, all infertility cases are not treatable, it has been reported that infertility causes in 40% of subjects are related to female factors, 40% are male factors and 20% are common factors^(7,8).

According to the World Health Organization report, over 70 million couples around the world and more than 1.5 million couples in Iran are suffering from this problem⁽⁴⁾. Long course of medical care compared  to affected population in Iran , patients socio-economic class which mostly belong to low-income category, the relatively high cost of medical care  and increasing growth rate of aging population are among the matters which has made the disease  noteworthy⁽⁹⁾.  Population-based studies are a good way to evaluate the prevalence of infertility. Several studies have been conducted to determine prevalence of infertility in the different communities and different results have been reported. The rate have been reported in China about 3%, in Scotland14% and in the Sheffield, Britain about 30 % ^(4,10). Several studies have been conducted to determine the infertility prevalence in Iran and the results were different. About one-fourth of the Iranian couples experience primary infertility during their married life, and 3.4% of couples are suffering from primary infertility at any time ⁽¹⁰⁾. There is a little accurate information about the prevalence of infertility in Iran right now. It seems for effective health care planning and for better understanding the problem, it is important to know this information in a systematic manner. Despite the positive changes in many areas of health care system in the last 3 decades in Iran, little attention has been paid to the issue of infertility data collection and infertility registration national system based on international standards.

Due to the increased infertility prevalence, it’s different definitions, and multiple estimations of emotional, financial burden of disease on  infertile couples quality of lives, as well as improper quality of medical care services, absence of a coherent national registration system, and since knowing exact pattern and infertility prevalence rate, is one of the indicators for health and family planning, we decided to examine the national  registry system  structure in the developed countries and compare it with the infertility clinics data in Iran in order to provide strategies for creating an electronic registry system and unique definition.

Materials and Methods

This was a comparative cross-sectional descriptive study that conducted in 2015. The research data resources were included retrieved infertility registry system and documents from the websites of the United States, United kingdown, Australia, Belgium and Japan. Selecting criteria of these countries was the possibility of access to their documents and being pioneer in the infertility medical care and interventional procedures. In this section, sampling was not done and all systems were reviewed. In these countries the retrieved documents was based on inclusion criteria. The inclusion criteria was included: retrieved  literature in English, access to full texts which was  published from 2000 to 2015 and also  receive definition and components  data via e-mail from the web-site managers. Resources for Iran was the research website, public and private documents and paper files of the infertility clinics in Tehran (10centers), respectively.

Based on the literature review data collection tool was, a data extraction form that developed by literature review and previous studies on data elements of information systems determining. Data extraction form was divided in to three main sections that included, basic patients information, past medical history and medical plan based on the initial retrieved literature website review, experts view in the field of the infertility, Ministry of Health experts and health information management experts.

Iranian and selected countries’ websites and documents were examined. Data were extracted and entered on separate forms for Iran and each other country. Then the data was integrated and provided as a list. Selected countries, data elements were translated into Persian. The final data elements content validity was confirmed by seven experts (three PhD in Health Information Management, three infertility specialist and one community medicine specialist). Then six columns in names of countries were placed in front of each data element, and availability of each data element was determined according to preliminary data elements extracted from the country. At last data elements were compared and presented in descriptive tables.

Results

According to conducted survives  in the countries, studied systems as well as the infertility clinics  in Iran, the results were divided into three categories that have been mentioned in the following table. Basic information of patients/ clients

The patients/ clients basic information including filing, archiving and demographic information that was available on other countries, information system and written information in Iranian infertility clinics, is shown (table no.1).

IRAN

United States

Australia

United kingdown

Belgium

Japan

Country data element

F

M

F

M

F

M

F

M

Donor

F

M

Female

Male

*

*

*

*

*

*

Unit identifier

Unit Information

*

*

*

Site of the Unit

*

*

*

*

completion date

*

*

*

*

*

*

Medical Record Number

Demographic Information

*

*

*

*

*

*

*

*

*

*

*

Full Name(Surname, First name)

*

*

*

First name(s) & Surname at birth

*

*

Known As/ Nick name

*

Maiden Name

*

*

*

*

*

*

Age at the time of the start of therapy

*

*

*

*

*

*

*

*

*

*

*

Date of birth

*

*

*

*

*

Country of birth

*

*

*

*

Birth place

*

Gender

*

*

*

Passport/ID Card Number

*

*

Father’s Name

*

*

Education

*

*

*

*

*

*

*

*

*

Address

*

*

*

*

*

*

*

Home Phone

*

*

*

*

Work Phone

*

*

*

*

Cell Phone

*

*

*

Fax, Email, Alternate Phone

*

*

Social Security No.

*

*

Employer

*

*

*

*

*

*

Occupation

*

*

Employment Status

*

*

*

*

*

Ethnic origin

*

Ancestry

*

*

Religious Preference

*

*

Parent’s Relationship

*

Type of relationship

*

Duration of Relationship

*

*

*

Marital Status

*

*

*

Length of marriage

*

*

Relationship With Husband

*

*

*

*

Past Marriage History

*

*

*

Duratin of Infertility (years)

*

*

Primary/Secondary

*

*

*

*

Patient Insurance

Insurance Information

*

Use of governmental support system for ART

*

*

*

*

*

Physician Name(firstname & Surname)

Physician

*

*

*

Address

*

*

*

Phone(Telephone)

*

*

Provider no.

*

*

email

*

*

*

Specialty

*

In case of emergency notify:Phone

*

Need to interpreter

Signature

*

*

*

Patient’s Signature

*

*

*

*

Date

*

*

*

Partnre/Spouse’s Signature

*

*

*

Date

*

*

*

Donor number,

Donor

Date(s) of donation(s),

Date gametes produced for use,

Any donations at other centres,

Marital StatusHistories

 

Table 2: shows the patient, past medical history , sexual behavior , previous obstetric  history, previous treatments and …..

IRAN

United States

Australia

United kingdown

Belgium

Japan

Country data element

F

M

F

M

F

M

F

M

Donor

F

M

Female

Male

*

*

*

*

*

*

Unit identifier

Unit Information

*

*

*

Site of the Unit

*

*

*

*

completion date

*

*

*

*

*

*

Medical Record Number

Demographic Information

*

*

*

*

*

*

*

*

*

*

*

Full Name(Surname, First name)

*

*

*

First name(s) & Surname at birth

*

*

Known As/ Nick name

*

Maiden Name

*

*

*

*

*

*

Age at the time of the start of therapy

*

*

*

*

*

*

*

*

*

*

*

Date of birth

*

*

*

*

*

Country of birth

*

*

*

*

Birth place

*

Gender

*

*

*

Passport/ID Card Number

*

*

Father’s Name

*

*

Education

*

*

*

*

*

*

*

*

*

Address

*

*

*

*

*

*

*

Home Phone

*

*

*

*

Work Phone

*

*

*

*

Cell Phone

*

*

*

Fax, Email, Alternate Phone

*

*

Social Security No.

*

*

Employer

*

*

*

*

*

*

Occupation

*

*

Employment Status

*

*

*

*

*

Ethnic origin

*

Ancestry

*

*

Religious Preference

*

*

Parent’s Relationship

*

Type of relationship

*

Duration of Relationship

*

*

*

Marital Status

*

*

*

Length of marriage

*

*

Relationship With Husband

*

*

*

*

Past Marriage History

*

*

*

Duratin of Infertility (years)

*

*

Primary/Secondary

*

*

*

*

Patient Insurance

Insurance Information

*

Use of governmental support system for ART

*

*

*

*

*

Physician Name(firstname & Surname)

Physician

*

*

*

Address

*

*

*

Phone(Telephone)

*

*

Provider no.

*

*

email

*

*

*

Specialty

*

In case of emergency notify:Phone

*

Need to interpreter

Signature

*

*

*

Patient’s Signature

*

*

*

*

Date

*

*

*

Partnre/Spouse’s Signature

*

*

*

Date

*

*

*

Donor number,

Donor

Date(s) of donation(s),

Date gametes produced for use,

Any donations at other centres,

Marital Status

 

Table 3: Information about the disease etiology and the type of treatment has been shown

 

IRAN

United States

Australia

UK

Belgium

Japan

Data  element                                  country

F

M

F

M

F

M

F

M

F

M

F

M

*

*

*

*

*

*

*

*

*

*

Ovulatory Dysfunction-disorders of ovulation(failure to release eggs) in fresh, non-donor cycles

Cause of infertility

*

*

*

*

*

*

*

*

*

*

Diminished Ovarian Reserve (Infertility resulting from decreased egg numbers in fresh, non-donor cycles)

*

*

*

*

*

*

*

*

*

*

Endometriosis (infertility resulting from the abnormal presence of uterine lining tissue outside of the uterus in fresh, non- donor cycles)

*

*

*

*

*

*

*

*

*

*

Uterine Factor (Infertility associated with diseases or abnormalities of the uterus in fresh, non donor cycles(Yes/No))

*

*

*

*

*

*

*

*

*

*

Male Factor (Infertility caused by problems with sperm in fresh, non-donor cycles. This includes decreased sperm numbers or absence of sperm. This also would inlude problems with sperm movement(motility) or function(Yes/No))

*

*

*

*

*

*

*

*

*

*

Other Factor(Infertility associated with other identificable problems not specifically listed in fresh, non donor cycles in fresh, non donor cycles)

*

*

*

*

*

*

*

*

*

*

Unknown Factor (Infertility for which no cause(male or female) is determind despite a through evaluation of both partners in fresh, non-donor cycles)

*

*

*

*

*

*

*

*

*

*

Multiple Female Factor(Female only)/ Other female factors(Infertility associated with more than one problem in fresh, non-donor cycles where all identified problems are female)

*

*

*

*

*

*

*

*

*

*

Female and Male Factor(Infertility caused by both male and female issues in fresh, non-donor cycles)

*

menopausal

*

ovarian failure

*

*

avoidance of genetic disorder

*

Diagnostic Laparoscopy

Female Tests

(looking inside the abdomen)

*

Hysteroscopy

(looking inside uterus)

*

Hysterosalpingogram(HSG)

(x-ray of tubes and uterus)

*

Karyotype

*

Hystero Sonography

*

*

*

*

Azoospermia/Cause of no transfer – No sperm

Male Tests

*

Oligozoospermia

*

*

Semen Analysis Only(SA)

*

Semen Analysis & Sperm DNA

Fragmentation Test

*

Mumps

*

M.orcchitis

*

U.D.T

*

Hypertension

*

Test. Pain

*

UTI

*

DM.

*

T.B

*

Allergy

*

Renal DZ.

*

Epididymitis

*

*

*

*

*

*

*

*

Number of cycles, Cycles resulting in pregnancies, Cycles resulting in live births, Retrievals resulting in live births, Transfers resulting in live births, Cycles with elective single embryo transfer, Cancellations, Implantation Rate, Number of embryos transferred, Live births with twins, Live births with triplets or more

Fresh Embryos From Non-Donor Eggs

*

*

*

*

Number of Transfers, Transfers resulting in live births, Average number of embryos transferred, Number of cycles, cycles where thaw was attempted that resulted in live birth

Thawed Embryos From Non-Donor Eggs

*

*

*

*

*

*

*

*

Age of oocyte/embryo donor, Date of intra-uterine insemination, Number of Cycles, Recipient starts resulting in live birth, Number of Transfers, Transfers resulting in live births, Average number of embryos transferred

Donated Eggs and Embryos (all ages)

*

Unique identification of each cycle

*

The date the cycle started

*

Surrogacy arrangement

Treatment

*

FSH stimulation

*

*

*

OPU(oocyte pickup) date

*

*

*

Number of eggs retrieved

*

*

Number of eggs donated

*

*

*

*

*

Number of eggs IVF

*

*

*

2pn – IVF

*

*

*

*

Number of eggs GIFT

*

*

*

ZIFT

*

PESA

*

TESA

*

*

IUI cycle

*

*

Long cycle

*

*

Natural Freeze cycle

*

*

Mix cycle

*

*

Antagonist cycle

Discussion and Conclusion

Due to our society cultural structure, infertility takes a deeper dimension, and could be considered as one of the reasons for divorce. Thus infertility is associated with many social aspects. The infertility medical care cost is another important issue that will affect the individual ⁽⁴⁾. Therefore, existence of an electronic registry system that includes different aspects of infertility and be helpful in terms of medical and economic that is crucial. Researchers believe that preventive and Continues Quality Improvement plans development, health care costs estimation, productivity, epidemiological studies, decision-making, organization, planning is not possible, without a comprehensive, structured and  valid registration system . Due to it’s importance, design and implementation of an infertility electronic registration system is priority of health systems in many developed countries like the United States, United Kingdown, Australia, Belgium and Japan. Surveys carried out in Iran, confirms that infertility contraceptives and management faces challenges due to lack of access to related data ⁽²⁾. Accordingly, in this study data elements from infertility health care centers compared with entered data elements of infertility electronic registration systems of United States, United Kingdown, Australia, Belgium and Japan.

Comparison of patient basic information and infertility health care centers in Iran with the mentioned countries registry systems were shown in table 1. Several factors of demographic data were examined. One of these factors, was individual age at onset of treatment. Because of importance of reproductive age and its effect on oogenesis & spermatogenesis in female and  male, as well as the production of healthy sperm’s genetic repair system , it seems to be  very important to be  examined. It is recorded in the America and Japanese system too ^(11,12). Racial investigation was recorded in the USA and UK infertility registry system due to large genetic differences resulted from immigration and breed difference ^(11,13). Racial differences was not recorded in Iranian clinics. But according to Iran’s vastness and different ethnic groups with different genetic predisposition in the country, it seems to be an essential and a   future need. Since family relationship of the couple can affect fertility genetically, it were present in information extracted from the Iranian clinics. The consanguineous marriage is not common in other countries, this is not mentioned in the other studied countries results. Due to the social and religious norms in Iran that sex and childbearing only is permitted in marriage the “relationship of men and women” element did not exist in information obtained from Iran. “Marital status” element did not exist in Iranian infertility registry system recording, but is recorded for female in USA, UK and Australia registry system ^(11,13,14) . Recording “length of marriage” element is important to understand the active pregnancy prevention and documented for USA and Iranian female clients ⁽¹¹⁾.” Infertility period “element means not childbearing, despite having sex intend to be fertile. This element is very important in disease prognosis and better medical care solutions. This data element was part of infertility registry system in Iranian and UK systems ⁽¹³⁾.

In Table 2 which includes the history section several factors were examined. One of these elements was “menstrual cycle” Which is important in terms of regularity, which its causes could be different and determining them is effective in treatment processes. This item was available in Iran’s website, and also were listed in the in Australia, USA and UK system ^(11,13,14). Information related to the “live birth numbers element” was recorded in Iranian clinics, this  element can show the individual ability for  productivity, regardless of genetic or newborn disease or prematurity . This element was not mentioned in the studied country registry system and could be due to differences in the data entry. “Abortion (intentionally or unintentionally) and the Ectopic Pregnancy” Elements were presented in obtained information from Iran and also existed in USA and Australia registration systems ^(11,14). “Contraception” element is also important due to the effect on selecting choice medical care plan. This element is exist in extracted information from Iranian  men and women, however in USA and Australia it  is just  indicated only for women, which could  be due to social and cultural differences in the one of the spouses contraceptive methods selection ^(11,14). Also different kinds of medications and reproductive health practices have been mentioned in USA system that because of multiplicity, it has not been investigated in Iran ⁽¹¹⁾. Due to the impact of overweight and obesity factors and its consequences the “weight” in Iran, USA, UK and Australia are listed. To calculate the body mass Similar to Australia, USA and UK “The height” of individuals were existed in Iranian information ^(11,13,14). Some underlying disease were also investigated, for example, “diabetes” that effect on internal organs and even sexual organs indirectly and cause infertility and miscarriage. It is listed in Iranian, USA and Australia systems ^(11,14). The “Tuberculosis diagnosis” obtained from studies of Iranian clinics as well as USA website, due to the high incidence rate of the disease and its effects on internal organs ⁽¹¹⁾. Another issue related to women’s infertility is “Endometriosis” that because of the rising trend in Iran, was considered in conducted studies of Iranian clinics as well as in USA and Australia systems ^(11,14). “Galactorrhea” or withdrawal of milk from the breast ducts without labor are signs of infertility and hormonal disorders. As well as “Hirsutism” in women could also be another sign of hormonal disorders. “Thyroid disturbances” is among other hormonal disorders. All of the above mentioned elements was gathered from infertility clinics information in Iran also presented in the USA system ⁽¹¹⁾. Stressful situations, “neurological problems” that effected on various parts of the body also affects fertility that regarding to Iranian living condition was investigated and also existed in USA infertility registration system ⁽¹¹⁾.  But this issue has not mentioned in the UK, Belgium and Japan systems that could be due to differences in lifestyle and socio-economic conditions ^(12,13). Due to the spread of self-medication and OTC administration in Iran, taking “OTC medicines,” was an important item to Iranian clinics, but it wasn’t in the UK, Japanese, Belgium and Australia systems ^(12-14). Due to the prevalence of “substance abuse” (cocaine, heroin and marijuana) in USA and its impact on infertility, data was obtained in USA national system ⁽¹¹⁾. Although “substance abuse” element in Iran, is not very common, but for better result it has been taken in Iran. Due to high rate of “smoking” in our country as well as Australia and USA systems, smoking is investigated in Iran and USA & Australia ^(11,14). Also “liquor use” due to religious factors is not common in Iran and was not considered in infertility clinics studies, while it is listed in the USA and Australia systems ^(11,14). Part of the care program, is about the “infertility causes” .The infertility etiology is various and is including factors related to fallopian tubes, infertility caused by the abnormal presence of uterine lining tissue outside the uterus in women and sperm parameters as male factor. These factors were on website of all studied countries, as well as information obtained from Iran’s ^(11-14). Regarding  the above  mentioned items and the growing trend of infertility in the country, there is necessity of an integrated infertility registry information system in Iran. A system that fits the norms of our society and cultural condition, help to improve the clients/ patients medical care condition, reduce the imposed costs, and due to the information s comprehensiveness, even is important for future researches.

Acknowledgments

This research was supported by Tehran university of medical sciences, Allied medical sciences school, Health Information Management department. The authors wish to thank the infertility registry sites managers for responding the data requests with goodwill.

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